QXY · Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

Cardiovascular · 21 CFR 870.1135 · Class 2

Overview

Identification

The Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ) and BP5460 (HEM-7372T1-AZAZ)) is an oscillometric-based, over-the-counter, upper arm blood pressure monitor intended for use in adults (22 years or older) to measure blood pressure and pulse rate. It includes an AFib detection feature that analyzes pulse pressure wave data captured during blood pressure measurement to identify episodes of atrial fibrillation and provide a notification on the display screen. It is intended for home screening for the possibility of AFib and is not intended to replace traditional diagnosis or treatment or to be used in the management of patients with known AFib.

Classification Rationale

Class II (special controls). The device is classified as Class II under 21 CFR 870.1135, subject to special controls to mitigate risks such as false positives, false negatives, and misinterpretation of device output.

Special Controls

In combination with the general controls of the FD&C Act, the oscillometric-based, over-thecounter, atrial fibrillation notification feature is subject to the following special controls: - 1) Clinical performance testing must compare the device algorithm performance against readings from patients with and without AFib that have been clinically adjudicated and evaluate the sensitivity and specificity of the output measurement. Justification for the clinical adjudication procedures to determine ground truth must be provided. - 2) Non-clinical performance testing of the algorithm must include: - a. Evaluation and qualification of interoperability with the oscillometric hardware components; and - b. Validation of the device to detect adequate motion/noise artifacts during measurement. - 3) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the diagnostic algorithm and its inputs and outputs. - 4) Human factors and usability testing must demonstrate the following: - a. The user can correctly use the device based solely on reading the device labeling; - The user can correctly interpret the device output and understand when to seek b. medical care; and - c. The user understands situations during which the device should not be used. - 5) Labeling must include: - a. A description of what the device measures and outputs to the user; - b. Situations in which the device may not operate at an expected performance level and when its use may pose risks to the user; - c. A summary of the clinical performance testing conducted with the device, including user demographics; - d. Guidance on interpretation of any measurements, detection results, and error messages: and - e. Hardware platform requirements.

Recent Cleared Devices (1 of 1)

Top Applicants

• Omron Healthcare, Inc. — 1 clearance